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<p class=MsoNormal><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;color:black;font-weight:bold'>FYI</span></font></b></p>
<p class=MsoNormal><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;color:black;font-weight:bold'> </span></font></b></p>
<p class=MsoNormal><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;color:black;font-weight:bold'>AP
News </span></font></b></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>Sep
11, 12:04 PM EDT</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'> </span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>U.S.</span></font><font
size=1 color=black face=Verdana><span style='font-size:9.0pt;font-family:Verdana;
color:black'> reports of drug reactions triple </span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color="#003366"
face=Verdana><span style='font-size:7.5pt;font-family:Verdana;color:#003366'>By
LINDSEY TANNER </span></font><font size=1 color=black face=Verdana><span
style='font-size:9.0pt;font-family:Verdana;color:black'><br>
AP Medical Writer</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>CHICAGO
(AP) -- Reports of dangerous side effects and deaths from widely used medicines
almost tripled between 1998 and 2005, an analysis of U.S. drug data found.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>The
number of deaths and serious injuries from prescription and over-the-counter
drugs climbed from 34,966 to 89,842 during the study of reports to the Food and
Drug Administration.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>Potent
narcotic painkillers including Oxycontin, sold generically as oxycodone, were
among 15 drugs most often linked with deaths in the study. Drugs frequently
linked with serious nonfatal complications included insulin, the arthritis
drugs Vioxx and Remicade, and the antidepressant Paxil.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>The
report adds to recent criticism of FDA oversight on drug safety, including its
handling of serious problems connected with Vioxx, which was removed from the
market in 2004.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>"This
growing toll of serious injury shows that the existing system is not adequately
protecting patients and underscores the importance of recent reports urging
far-reaching legislative, policy and institutional changes," the authors
said.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>The
analysis appears in this week's issue of Archives of Internal Medicine. Its
authors are Thomas Moore and Michael Cohen of the Institute for Safe Medication
Practices, a nonprofit educational group that analyzes drug safety issues; and
Dr. Curt Furberg of Wake Forest University School of Medicine.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>They
analyzed excerpts of reports on serious side effects received by the FDA
between January 1998 and December 2005. A total of 467,809 serious
complications were found. Reported deaths nearly tripled, rising from 5,519 to
15,107.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>A
disproportionate number of complications occurred in elderly patients. Women
were more often victims than men, 55.5 percent compared to 45.5 percent.
Children were involved in 7.4 percent of the problems.</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>The
FDA issued a statement saying it is aware of the growing number of reported
problems and takes them seriously, but the reason for the increase "is not
completely known."</span></font></p>
<p class=MsoNormal style='line-height:9.75pt'><font size=1 color=black
face=Verdana><span style='font-size:9.0pt;font-family:Verdana;color:black'>"While
some of this has to do with the increasing number of prescriptions, there are
clearly other factors responsible for this increase, such as the increase in
public attention to drug safety, and use of the Internet to make it easier for
the public to submit," Dr. Gerald Dal Pan of the FDA's surveillance and
epidemiology office said in the statement.</span></font></p>
<p class=MsoNormal><font size=1 color=black face=Verdana><span
style='font-size:9.0pt;font-family:Verdana;color:black'>Sen. Charles Grassley,
an Iowa Republican and frequent FDA critic, said the report is another
indication that the FDA's review of drugs already on the market "must be
rigorous and timely."</span></font></p>
<p class=MsoNormal><font size=1 color=black face=Verdana><span
style='font-size:9.0pt;font-family:Verdana;color:black'> </span></font></p>
<p class=MsoNormal><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;color:black;font-weight:bold'><a
href="http://hosted.ap.org/dynamic/stories/D/DRUG_REACTIONS?SITE=WHIZ&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2007-09-11-12-04-07"><font
face="Times New Roman"><span style='font-family:"Times New Roman"'>http://hosted.ap.org/dynamic/stories/D/DRUG_REACTIONS?SITE=WHIZ&SECTION=HOME&TEMPLATE=DEFAULT&CTIME=2007-09-11-12-04-07</span></font></a>
</span></font></b></p>
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<p class=MsoNormal><strong><b><font size=2 color=navy face="Palatino Linotype"><span
style='font-size:10.0pt;font-family:"Palatino Linotype";color:navy'>Emma
Johnson</span></font></b></strong></p>
<p class=MsoNormal><em><i><font size=2 color=navy face="Palatino Linotype"><span
style='font-size:10.0pt;font-family:"Palatino Linotype";color:navy'>Solid Waste
and Financial Assistance</span></font></i></em></p>
<p class=MsoNormal><em><i><font size=2 color=navy face="Palatino Linotype"><span
style='font-size:10.0pt;font-family:"Palatino Linotype";color:navy'>Washington
Department of Ecology</span></font></i></em></p>
<p class=MsoNormal><em><i><font size=2 color=navy face="Palatino Linotype"><span
style='font-size:10.0pt;font-family:"Palatino Linotype";color:navy'>425-649-7266</span></font></i></em></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
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face="Palatino Linotype"><span style='font-size:10.0pt;font-family:"Palatino Linotype";
color:navy;text-decoration:none'>ejoh461@ecy.wa.gov</span></font></i></em></a></span></font></p>
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